NCT04320732

Brief Summary

The project is an epidemiological observational study based on an electronic questionnaire on risk factors for COVID-19 in the community and healthcare setting.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250,000

participants targeted

Target at P75+ for all trials

Timeline
45mo left

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Mar 2020Mar 2030

First Submitted

Initial submission to the registry

March 23, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

March 27, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2030

Expected
Last Updated

December 13, 2021

Status Verified

November 1, 2021

Enrollment Period

5 years

First QC Date

March 23, 2020

Last Update Submit

November 29, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of COVID-19 infection

    Diagnosed with serology or direct viral detection

    1 year

Study Arms (5)

Individuals with COVID-19 infection

Confirmed by routine laboratory diagnosis. All types of COVID-19 disease from asymptomatic carriers to hospitalized patients can be included. Only subjects \>18 years old will be included in the study.

Behavioral: Observation of behavior and COVID-19 infection will be conducted.

Individuals tested for COVID-19 infection with negative test

Confirmed by routine laboratory diagnosis

Behavioral: Observation of behavior and COVID-19 infection will be conducted.

Healthy individuals

Recruitet from the general population

Behavioral: Observation of behavior and COVID-19 infection will be conducted.

Risk groups for COVID-19 exposure

Including, but not limited to healthcare workers.

Behavioral: Observation of behavior and COVID-19 infection will be conducted.

Patients admitted to hospital

Without COVID-19 infection.

Behavioral: Observation of behavior and COVID-19 infection will be conducted.

Interventions

No intervention, only prospective observation of behavior will be conducted by a questionnaire.

Healthy individualsIndividuals tested for COVID-19 infection with negative testIndividuals with COVID-19 infectionPatients admitted to hospitalRisk groups for COVID-19 exposure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study will be a combined retrospective and prospective case-control study based on a combined electronic consent form and questionnaire that the study groups will fill in using a smartphone and electronic identification. The groups that will be included are: * Hospitalized and non-hospitalized patients/persons with COVID-19 at all stages of the disease and after the disease * Hospitalized patients without COVID-19 * Healthcare personal or other groups with an increased risk of COVID-19 * Healthy volunteers Probability sampling will be conducted, but not solely.

You may qualify if:

  • Norwegian adult

You may not qualify if:

  • Unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and upper repiratory samples will be collected from some participants.

MeSH Terms

Conditions

Coronavirus Infections

Interventions

Behavior Observation Techniques

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Psychological TechniquesInvestigative TechniquesBehavioral Disciplines and Activities

Central Study Contacts

John Arne Dahl, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, MD, PhD

Study Record Dates

First Submitted

March 23, 2020

First Posted

March 25, 2020

Study Start

March 27, 2020

Primary Completion

March 27, 2025

Study Completion (Estimated)

March 20, 2030

Last Updated

December 13, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

European GDPR regulations severely limits IPD, but the study will share data to the largest extent possible within GDPR.

Locations